French Public Health Code
In forceI.-In accordance with the provisions of II of Article L. 4211-9-1, an establishment or organisation authorised under this section may have the preparation and distribution of an individually prepared advanced therapy medicinal product as mentioned in Article R. 1124-6 and in the second paragraph of Article R. 5121-209, by the health establishment or army hospital which removes the autologous tissues or cells, i.e. from the person himself, used in its composition, when all the stages from removal to administration are carried out as part of a single medical procedure and in the same room.
In this case, the authorised establishment or organisation must first conclude a written contract with the health establishment or army hospital which prepares and distributes the advanced therapy medicinal product prepared on an ad hoc basis.
When the authorised establishment is the health establishment or army hospital in which the autologous tissues or cells are removed, and then the advanced therapy medicinal product prepared as required is prepared, distributed and administered, a written document sets out the division of roles between the authorised establishment and the care structures or units removing the tissues or cells and administering the said medicinal product.
The provisions of sub-sections 1 to 4 are applicable subject to the following provisions.
II.-As part of the application for authorisation mentioned in article R. 4211-34, the dossier submitted by the legal entity applying for this authorisation must also include the following information:
1° The name, address and department of the health establishment or army hospital in which the preparation and distribution is carried out;
2° A plan of the room where the preparation and distribution is carried out;
3° A precise description of the equipment and materials used for the preparation of the medicinal product;
4° The list and qualifications of the staff dedicated to preparation and distribution, in particular that of the person designated as responsible for these activities in the health establishment or army hospital;
5° The contract or draft contract between the health establishment or army hospital and the legal entity applying for authorisation;
6° Where applicable, the written document drawn up in application of the third paragraph of I of this article;
7° The list of procedures used in the context of this activity.
Articles R. 4211-34 to R. 4211-36 are applicable to the examination of the application for authorisation.
III.-The authorisation referred to in article R. 4211-36 includes a reference to the performance, during a single medical procedure within the meaning of II of article L. 4211-9-1, of the removal of autologous tissues or cells, the preparation, distribution and administration of the advanced therapy medicinal product prepared on a one-off basis.
IV. -The following constitute substantial changes under article R. 4211-43 :
a) The addition of the activity of preparation and distribution as part of the same medical procedure as that for the removal of autologous tissues or cells;
b) The addition of a new health establishment or army hospital carrying out preparation and distribution as part of the same medical procedure as that for the removal of autologous tissues or cells;
c) The addition of a new type of advanced therapy medicinal product prepared on an ad hoc basis;
d) Changes relating to the organisation of these activities, including changes to the contracts or written documents drawn up in application of I of this article when these changes concern the quality and safety of the medicinal product.
Applications for authorisation to make changes are examined in accordance with the provisions of article R. 4211-43.
V.-Amendments relating to contracts or written documents drawn up in application of I, other than those mentioned in IV, which have no impact on the quality and safety of the medicinal product, are amendments subject to declaration under the conditions set out in article R. 4211-44.
VI.-The annual activity report mentioned in article R. 4211-47 also includes the list of health establishments and army hospitals with which the establishment or authorised body has entered into a contract in application of I of this article.
VII - The responsible person mentioned in article R. 4211-37 is also responsible for ensuring that the provisions of this sub-section are complied with and in particular that the health establishment or army hospital complies with its obligations with regard to the preparation and distribution of advanced therapy medicinal products prepared on an ad hoc basis as part of the same medical procedure as that for the removal of the autologous tissues or cells used in their composition.
